MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH BUBBLE SENSOR S5; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	23-45-20
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland has received a report that during a procedure, the level/bubble sensor issues displayed triangle warning.The would come back to normal and switch back intermittently.There is no report of any patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in (b)(6), united states of america.As per follow up with the perfusionist, during the case intermittently they would get a triangle warning on the level and/or bubble sensors at different times.When the warning would clear on its own the level and bubble would work properly and show that it was connected to the scp panel.No ¿alarm¿ (red) ever appear during the case ¿ pump never stopped or erc was never initiated to close.They didn¿t test it anymore because they were in a case.A field service engineer was dispatched to the customer site and the issue was confirmed.Unplugged sensor and re-inserted sensor, and the warning triangle did not clear.I did this a couple of times and then the bubble sensor worked properly.Additionally, display was- flashing and not booting up (intermittently).I moved the screen to another slot and re booted the s5 system and the ¿flickering¿ display was blank and no power.The bubble module, the level module and the dc/dc module were changed.Finally, also the touch screen was changed.After changing modules - system booted up and both icons (bubble/level) were stable and would show up on the scp panel (assigned) sensors would alarm correctly.It was not possible to verify if the issue would affect how the sensor was working.Once i got it to read the sensor (yellow triangle gone) sensor worked as it is expected.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H10: complaints database analysis revealed that no similar event on this device occurred since its installation in 2007.Based on all the collected information, it can be concluded that the case was due to an intermittent electrical failure, likely caused by a level and a bubble sensors fault.
Event or Problem Description
See initial report.

• Brand Name: BUBBLE SENSOR S5
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17369862
• Report Number: 9611109-2023-00344
• Device Sequence Number: 3784571
• Product Code: DTQ
• UDI-Device Identifier: 04033817900665
• UDI-Public: (01)04033817900665(11)230425
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K210130
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 23-45-20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown